Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial

BMC Nephrology

J Brian Copley⁴  Hong Wan⁴  Paul Wilde²  Peter Preston⁴  Karim Keddad³  Dominique Prié⁵  Pablo Ureña-Torres¹ 

[1]Service de Néphrologie-Dialyse, Clinique du Landy, Paris, France

[2]Shire, Basingstoke, UK

[3]Shire, Boulogne-Billancourt, France

[4]Shire, Wayne, Pennsylvania, USA

[5]Service de Physiologie-Explorations Fonctionnelles, Hôpital Necker-Enfants Malades, Paris, France

关键词: Lanthanum carbonate;    Phosphaturia;    Phosphate binders;    Parathyroid hormone;    FGF23;    CKD-MBD;   

Others  :  1082691
DOI  :  10.1186/1471-2369-15-71

 received in 2013-11-15, accepted in 2014-04-24,  发布年份 2014

【 摘 要 】

Background

High levels of circulating fibroblast growth factor 23 (FGF23) are associated with chronic kidney disease (CKD) progression and high mortality. In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment (PREFECT) study, we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3.

Methods

Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day (n = 23) or placebo (n = 12) for 12 weeks. Levels of intact FGF23 (iFGF23), C-terminal FGF23, serum and urinary phosphate and calcium, intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed.

Results

The median age was 65 years in the lanthanum group and 73 years in the placebo group; 58.8% and 41.7% were men, respectively. No significant difference was seen in mean iFGF23 between groups at week 12. There was, however, a transient reduction from baseline in iFGF23 in the lanthanum group at week 1, from 70.5 pg/ml to 51.9 pg/ml, which was not seen in the placebo group; this between-group difference in percentage change from baseline was significant in post hoc analyses (p = 0.0102). Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12.

Conclusions

Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3, although phosphaturia decreased. This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD.

Trial registration

ClinicalTrials.gov NCT01128179, 20 May 2010.

【 授权许可】

   
2014 Ureña-Torres et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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